Perspectives of researchers and clinicians on patient and public involvement (PPI) in preclinical spinal cord research: An interview study

Abstract Introduction Patient and public involvement (PPI) in research is an embedded practice in clinical research, however, its role in preclinical or laboratory‐based research is less well established and presents specific challenges. This study aimed to explore the perspectives of two key stakeholder groups, preclinical researchers and clinicians on PPI in preclinical research, using spinal cord research as a case study. Methods Semi‐structured interviews were conducted online with 11 clinicians and 11 preclinical researchers all working in the area of spinal cord injury (SCI). Interviews were transcribed verbatim and analysed thematically. Findings Nine themes were developed through analysis. Participants' perspectives included that people living with SCI had a right to be involved, that PPI can improve the relevance of preclinical research, and that PPI can positively impact the experiences of researchers. They identified the distance between lab‐based research and the daily experiences of living with SCI to be a barrier and proactive management of accessibility and the motivated and networked SCI community as key facilitators. To develop strong partnerships, participants suggested setting clear expectations, ensuring good communication, and demonstrating respect for the time of PPI contributors involved in the research. Conclusions While traditionally PPI has been more commonly associated with clinical research, participants identified several potential benefits of PPI in preclinical spinal cord research that have applicability to preclinical researchers more broadly. Preclinical spinal researchers should explore how to include PPI in their work. Patient or Public Contribution This study was conducted as part of a broader project aiming to develop an evidence base for preclinical PPI that draws on a 5‐year preclinical research programme focused on the development of advanced biomaterials for spinal cord repair as a case study. A PPI Advisory Panel comprising seriously injured rugby players, clinicians, preclinical researchers, and PPI facilitators collaborated as co‐authors on the conceptualisation, design of the interview protocol, data analysis and writing of this manuscript.

Findings: Nine themes were developed through analysis.Participants' perspectives included that people living with SCI had a right to be involved, that PPI can improve the relevance of preclinical research, and that PPI can positively impact the experiences of researchers.They identified the distance between lab-based research and the daily experiences of living with SCI to be a barrier and proactive management of accessibility and the motivated and networked SCI community as key facilitators.To develop strong partnerships, participants suggested setting clear expectations, ensuring good communication, and demonstrating respect for the time of PPI contributors involved in the research.

| INTRODUCTION
Patient and public involvement (PPI) is the active and meaningful engagement of patients and/or the public in the research process. 1 It is more commonly referred to as patient engagement in North America.At its core, PPI appreciates the experience and perspectives of those living with particular conditions in shaping and improving research and considers those who will be most affected by the results to have the right to an opportunity to input. 2,3PPI can involve patients and/or the public (often known as PPI contributors) at any stage of the research process, for example identifying research priorities, or informing dissemination strategies to share results with wider audiences. 1It can take many forms, from PPI contributors sitting on steering groups or committees to collaborating as coresearchers. 4A growing evidence base underpins the benefits of PPI in enhancing research quality and appropriateness, enhancing clinical study recruitment strategies, and improving the dissemination of findings. 26][7] Examples of successful partnerships in spinal cord research include the development of a set of research priorities for SCI. 8 However, the field of spinal cord research spans preclinical (including basic, fundamental, biomedical, translational, or lab-based research) and clinical (including rehabilitation, occupational, clinical trials) settings, and it is important to consider how involving PPI contributors can be optimised for these diverse contexts.While the evidence base for PPI in clinical research is well established and has become a recognised and important feature of research practice for key stakeholders including funding agencies, regulators, and journal editors, 2,4 the impact of PPI in the field of preclinical research has not been as comprehensively explored.
For PPI in preclinical research, the technical nature, need for specialist knowledge, and limited access to the laboratory environment has made it a less obvious setting for PPI. 9 This is reflected in the limited empirical evidence base for PPI in preclinical research identified in two recent reviews. 10,11The available literature indicates that researchers' perspectives on preclinical PPI reported vary, with some authors suggesting PPI can reduce waste, increase value, and improve the quality of preclinical research, but others caution that it is difficult to meaningfully involve patients and the public as PPI contributors in this context. 9,12Combined, the limited evidence base to underpin preclinical PPI and diverse perspectives reported there make it challenging for preclinical spinal cord research teams to find guidance on getting started.Due to the limited guidance on PPI for preclinical research, [10][11][12] and the importance of research participation to the SCI community, 13 it is timely to explore the role of PPI in preclinical SCI research.

| Design
This qualitative study used semistructured interviews to gather data from participants.This method combined a pre-determined set of questions (see Table 1) with the flexibility to explore particular responses further if needed.The Human Research Ethics Committee (REC) at the RCSI University of Medicine and Health Sciences provided ethical approval for the study (REC Record ID: 212494891).All participants provided written informed consent before participating in the study.

| Participants
Preclinical spinal cord researchers and clinicians involved in the treatment of SCI were eligible to participate.In this study, 'preclinical researchers' refers to research scientists working primarily in laboratory settings, and 'clinicians' refers to qualified medical doctors.
Researchers and clinicians at all stages of training/practice were eligible to take part.Participants were excluded if they had less than 6 months of experience working in their respective fields.

| Sampling and recruitment
Purposive sampling was used to identify eligible participants.For preclinical researchers, potential participants were first identified by their publishing record in the field of SCI and contacted via email.The introductory email contained an information leaflet, consent form, and contact details for the lead author of the current study (PC).PIs were asked to circulate the information leaflet to members of their research groups, who then contacted PC to arrange an interview if interested.
Clinicians were contacted and recruited using a similar process.The research study was also advertised using social media sites including Twitter and LinkedIn and the professional and personal networks of the research team.Participants were offered a €30 gift voucher in recognition of their time for participation.The study sample size was guided using the concept of information power to determine the number of participants needed. 16Due to the narrow study aim, specificity of the study to SCI, and experience of the interviewer, the aim to recruit approximately 10 participants for each group was agreed as a goal by team members. 16

| Data collection
The study PPI Advisory Panel provided feedback on questions and terminology and approved the interview guide before commencement of the interviews and collection of data.An abridged topic guide is included in Table 1.Participants were asked initial demographic questions, including information about their current role and any previous experience with PPI followed by open-ended questions relating to their perspectives on PPI in preclinical spinal cord research.Interviews were conducted by PC, a male PhD student with formal training and experience in qualitative research and interviewing and took place from March to May 2023.Interviews were conducted and recorded using Microsoft Teams and then transcribed verbatim by PC.

| Data analysis
All recorded and transcribed data was analysed inductively using the framework described by Braun and Clarke for thematic analysis (TA). 17Data was managed and organised using Microsoft (MS) Excel.
PC coded all the data and met twice weekly with MF during the analysis process to review coding, theme development, and challenges.Themes were generated using the following six phasesfamiliarisation, coding, generating initial themes, reviewing and developing themes, refining themes, and writing up. 17 2.

| Themes
The themes generated from the analysis are summarised in Figure 1 grouped under three subheadings (1) perspectives on PPI in preclinical research, (2) barriers and facilitators, and (3) developing partnerships in PPI for clarity.

Perspectives on PPI in preclinical research
Clinician and researcher participants reported having awareness of PPI as a concept, but their perspectives varied based on their level of experience with PPI and professional backgrounds.The clinicians tended to relate their understanding of PPI to their clinical experience in healthcare, for example, 'So, kind of involving patients as partners in their own healthcare.And I guess it's kind of a similar concept being carried over to research that we should involve the people' (Clinician 1) and researchers described learning about PPI as part of their research practice through attending conferences or writing grant funding applications.For a smaller number, they had direct experience with clinical PPI activities.Other studies have also referred to this gap as being potentially problematic. 21,22However, there are an increasing number of studies reporting the process and impact of PPI in preclinical research, and despite the concerns of the preclinical researchers and clinicians, it appears that with appropriate preparation and support it can be achieved. 10,11Proactively managing accessibility requirements reflects an important practical consideration to ensure that PPI contributors' needs are anticipated and met. 23Finally, the highly motivated and networked group of people affected by SCI were identified by several participants serves as an important facilitator and finding ways to connect with patient groups and individual PPI contributors can help researchers identify people willing to participate in PPI activities.This is encouraging for preclinical researchers.
To develop strong partnerships for preclinical PPI in spinal cord research, researchers should be mindful of communicating clear and realistic expectations, dedicating time and being honest, and respecting the time of PPI contributors.Clinicians emphasised that it would be important to clearly communicate the preliminary nature of research findings, as they believed people with SCI might develop high expectations for a cure from early research findings.This contrasts with views expressed by people living with SCI, who, in previous research conducted by the team, reported that being involved in PPI could have the opposite effect, that learning more about research would reduce their hope for a cure. 24The importance of developing strong relationships noted by study participants is generally accepted to be essential for successful PPI but can be challenging to achieve 23,25 and has formed the basis of a dialoguebased model for PPI in SCI. 13 Previous research on PPI in preclinical research indicated that researchers may feel that they lack the skills to communicate effectively with PPI contributors or patient organisations, however this was not a primary concern identified in this study. 21It is possible that the focus on communication skills as a core skill for all researchers has reduced this concern.Previous research also suggests that PPI improves researchers' abilities to communicate their findings to the wider public. 26,27Communication includes providing feedback to PPI contributors about research outputs from preclinical researchers, 28 but this was not mentioned by the study participants, which may highlight a need for this to be included in training sessions.Provision of feedback on the results of scientific studies may appear more challenging initially, but our own experience of including updates of research progress and findings has been positive.Another important consideration is providing payment for PPI contributors' time and expenses, which is increasingly considered to be essential and has led to the development of specific guidelines for researchers. 7is study adds to the small but growing empirical evidence base for PPI in preclinical spinal cord research. 10,11Our findings add support to other studies, indicating that in the context of PPI in preclinical spinal cord research that PPI provides an additional form of knowledge to preclinical research, 29 connects researchers with people's experiences, 26 and helps develops positive relationships between researchers and PPI contributors. 27 Panel highlighted this challenge when developing a strategy for our PPI work for a preclinical spinal cord repair regenerative medicine project.The study is a collaboration between the Irish Rugby Football Union (IRFU) Charitable Trust, a charity that supports rugby players living with SCI, and the Science Foundation Ireland Centre for Advanced Materials and BioEngineering Reserach (AMBER) hosted at Trinity College Dublin, in partnership with the RCSI University of Medicine and Health Sciences, and others.This ambitious multi-disciplinary project aims to develop an advanced scaffold-based platform combining stem cells, gene therapy, and electrostimulation aimed at providing a solution for spinal cord repair, 14,15 and is overseen by a PPI Advisory Panel consisting of preclinical researchers, clinicians, and people living with rugby-related SCI to help guide the research.As the PPI Advisory Panel became more established, it quickly became apparent that there was limited guidance available from the published literature, and a secondary aim to contribute towards an evidence base for PPI in preclinical spinal cord research was agreed.Since researchers and clinicians work closely with PPI contributors as part of PPI activities, we were interested in their perspectives and how this might influence preclinical spinal cord PPI.Clinicians are a particularly important group as they are conventionally aligned with preclinical research either as clinician-researchers or steering research to ensure translation of findings is possible.They can also provide important context as part of preclinical PPI by explaining how proposed treatments would differ from existing treatments.The aim of this study was thus to explore the perspectives of preclinical spinal cord researchers and clinicians involved in the treatment of SCI on PPI in preclinical research.It aimed to understand their perspectives on what the role and goals of PPI should be in preclinical spinal cord research and their views on potential benefits, barriers, and facilitators to gain a better understanding of PPI in this context.
Our findings indicate that preclinical spinal cord researchers and clinicians working in SCI appreciate the benefits of involving people affected by SCI can have for preclinical research.Barriers and facilitators identified by the participants may help inform the PPI activities of other preclinical research teams in spinal cord research and more broadly.While the perspectives of both groups were similar, their understanding of the role of PPI was based on their own professional backgrounds, which may lead to confusion or even conflict if these differences are not discussed.Training may help align diverse perspectives in advance of commencing PPI activities.Findings also broadly aligned with those from a previous study by the team that explored the perspectives of or may not be able to apply as opposed to if you start with clinicians and patients early, you know exactly what the problem is because you've asked the patients about the problem, you're not assuming the problem, and if you talk to clinicians, you think about what's applicable and what's not'.Participant demographics.
Both researchers and clinicians expressed support for PPI in preclinical spinal cord research based on the belief that people have a right to be involved in research that could directly impact their lives.PPI was considered important since public money frequently funds research: 'The public should be aware of what we're doing because their money has been used to pay for us' (Researcher 8) and since available funding is limited, it is important to ensure research is focused on achieving important patient goals rather than purely academic interests: In terms of things like spinal cord injuries or where you've got a much more distinct patient voice, it's more specific, and I guess if there is money being spent on research for a certain condition, we should definitely be asking them what they think that money F I G U R E 1 Summary of themes from analysis.PPI, patient and public involvement; SCI, spinal cord injury.relevanceThe majority of participants identified that PPI could improve the relevance and focus of preclinical research and prevent time being spent on ideas that would not have practical application: If you only had this PPI thing at the clinical stages of work, then your research effectively builds a product that you may Obviously, spinal cord injury is not exactly binary.This huge amount of physical and psychological and social aspects of spinal cord injury, and there's no kind of size fits all score or goal that you want to try to achieve.So, who (do) you want even involved in assessing what's important?And then also it's a very high-risk group as well.So it needs a lot of research.'It's(PPI) not going to impact my experiments' (Researcher 3), through the sharing of their experiences with researchers, they can still guide them to address particularly important challenges: I think the most useful, and best thing that can be done in the fundamental research, I would try to really T A B L E 2 PPI was also reported to serve as a source of motivation for researchers in the field: 'I feel like it brings a lot of benefit to the researchers, in terms of motivating them….andfor the patients who were involved, for hope and directing the outcomes' (Researcher 6).you believe it is ingrained in the fact that you might think it will take a few months, and then after that, if that keeps getting repeated and repeated and repeated, then you don't really see that light at the end of the tunnel.(Researcher11) Theme 2.3 The community of people affected by spinal cord injury is highly motivated and well networked Several clinicians explained that from their experience that people living with SCI are motivated and familiar with and interested in research: 'My experience of many people with spinal injuries, [they]are very motivated.They're very well-read around the whole area, so inviting them to be involved in the whole process would be very beneficial' (Clinician 11), 'Some of my patients are quite academic, and they would love to have a one-to-one with somebody to bounce ideas off' (Clinician 9).Others noted that they are well networked, and communicate well and so should be a facilitator for PPI: ing a research project 'Say if you work in research or you're working in healthcare, you might understand that a pre-clinical trial if it works, could be decades away from having an impact on actual clinical outcomes and I guess that would be the one bit in my mind, I'd want to be a little careful' (Clinician 5).Having a clear sense of the aim of PPI and how it would benefit people involved to prevent the development of 'false hopes' and being honest were considered I think that [rapport] will only come after time because people aren't generally, with some exceptions, going to have the confidence to say that in the first meeting.And so I think that that's why relationship building is so important to be like when we do the PPI work now we get great questions about it and very searching questions